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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 367958
Device Problems Component Incompatible (1108); Leak/Splash (1354)
Patient Problem Exposure to Body Fluids (1745)
Event Date 04/12/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that when the bd vacutainer® sst¿ ii advance plus blood collection tube was removed from the patient, the stopper popped out and blood spilt from the tube onto the floor.The needle remained in the patient's arm, where the lid of the tube was still attached, and blood continued to "flow out of the arm" and splashed the phlebotomist.A colleague was called in to help stop the bleeding by keeping pressure on the arm, before removing the tourniquet and needle, and cleaning up the blood.The phlebotomist was reportedly tested for blood borne diseases, but the tests were later deemed unnecessary, as the health professional's skin was intact and no puncture wound had occurred.The barrel of the tube was also noted to be tight in the holder during use.The following information was provided by the initial reporter: " blood collection for a patient proceeded as normal, blood flow adequate, no issues identified, patient calm.First tube collected, phlebotomist removed the sst tube ¿ the yellow top remained intact inside the barrel with the needle inside the patient.Blood was spilt from the tube and onto the floor, whilst the needle was still in the arm with the lid of the sst attached, blood continued to flow out of the arm, splashing the collector.The collector then called for help from a colleague.The collector stopped the bleed, removed tourniquet, removed needle and held pressure.Once the needle was disposed of, the collector removed her gloves then washed her hands and arms of the blood.The patient was initially concerned, but remained calm was cleaned up and moved to another room to complete the collection without incident.The phlebotomist has since been tested (routine requirement post needle stick injury) for blood borne diseases, however it has since been ascertained that this was not necessary as her skin is intact and there was no puncture wound.The staff member concerned stated that she held the barrel as she has many times previously, with moderate pressure.Other staff members in the clinic noted that whilst they find the single use barrels tight when using sst tubes, it has been ascertained that this is the first instance of its kind.".
 
Event Description
It was reported that when the bd vacutainer® sst¿ ii advance plus blood collection tube was removed from the patient, the stopper popped out and blood spilt from the tube onto the floor.The needle remained in the patient's arm, where the lid of the tube was still attached, and blood continued to "flow out of the arm" and splashed the phlebotomist.A colleague was called in to help stop the bleeding by keeping pressure on the arm, before removing the tourniquet and needle, and cleaning up the blood.The phlebotomist was reportedly tested for blood borne diseases, but the tests were later deemed unnecessary, as the health professional's skin was intact and no puncture wound had occurred.The barrel of the tube was also noted to be tight in the holder during use.The following information was provided by the initial reporter: " blood collection for a patient proceeded as normal, blood flow adequate, no issues identified, patient calm.First tube collected, phlebotomist removed the sst tube ¿ the yellow top remained intact inside the barrel with the needle inside the patient.Blood was spilt from the tube and onto the floor, whilst the needle was still in the arm with the lid of the sst attached, blood continued to flow out of the arm, splashing the collector.The collector then called for help from a colleague.The collector stopped the bleed, removed tourniquet, removed needle and held pressure.Once the needle was disposed of, the collector removed her gloves then washed her hands and arms of the blood.The patient was initially concerned, but remained calm was cleaned up and moved to another room to complete the collection without incident.The phlebotomist has since been tested (routine requirement post needle stick injury) for blood borne diseases, however it has since been ascertained that this was not necessary as her skin is intact and there was no puncture wound.The staff member concerned stated that she held the barrel as she has many times previously, with moderate pressure.Other staff members in the clinic noted that whilst they find the single use barrels tight when using sst tubes, it has been ascertained that this is the first instance of its kind.".
 
Manufacturer Narrative
Investigation: investigation summary: bd received samples from the customer facility for investigation.The samples were tested/evaluated and the customer's indicated failure mode for decapping with the incident lot was not observed as all product specifications were met.A review of the manufacturing records was completed for the incident lot and no issues were identified.Investigation conclusion: based on evaluation of the customer samples, the customer¿s indicated failure mode fordecapping with the incident lot was not observed as all samples met the required specifications.Root cause description: based on the investigation, a root cause could not be determined.The product was found to be in conformance and meet release specifications.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
 
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Brand Name
BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY (BD)
belliver way
belliver industrial estate
plymouth
MDR Report Key8600159
MDR Text Key144803608
Report Number9617032-2019-00576
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
PMA/PMN Number
BK050036
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 05/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2020
Device Catalogue Number367958
Device Lot Number8285613
Date Manufacturer Received04/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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